4
Introduction and Intended Use
The 9002 digital ADC
®
e-sphyg
TM
2 sphygmomanometer is a digital sphygmo-
manometer intended for measurement of systolic and diastolic blood pressure
and pulse rate in adult patients, i.e., age 12 and above. This product is not de-
signed for neonatal use. Inaccurate readings may result if it is used on a child's
arm.
Accuracy was evaluated during clinical studies in which results with the 9002
digital ADC
®
e-sphyg
TM
2 sphygmomanometer were compared with simultane-
ous auscultatory measurements obtained with a standard sphygmomanometer.
In these studies, the onset of the fourth (or fifth) Korotkoff sound was taken as
the diastolic pressure for the purpose of determining overall efficacy. A copy of
this study is available from ADC
®
on request. To ensure that accuracy is main-
tained, compare readings obtained with the 9002 digital ADC
®
e-sphyg
TM
2
sphygmomanometer with values measured by a trained observer using a manual
sphygmomanometer at least every 6 months.
Blood pressure measurements determined with this device are equivalent to those
obtained by a trained observer using the cuff stethoscope auscultatory method,
within the limits prescribed by the American National Standard, Manual, electronic,
or automated sphygmomanometers.
The 9002 digital ADC
®
e-sphyg
TM
2 sphygmomanometer has the ability to func-
tion according to its specifications in the presence of common arrhythmia such
as atrial or ventricular premature beats or atrial
fibrillation.
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